Manager, Product Transfer

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The Position

A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche. 

The Opportunity

Roche is the world’s #1 provider of companion diagnostics, offering unrivaled experience in developing and commercializing predictive tests that enable personalized treatment strategies for patients.

The Manager, Product Transfer position is responsible for leading the transfer of newly developed assays from R&D to manufacturing. This position will be instrumental in leading key decision makers in a matrix environment between the R&D departments and the commercial manufacturing operations.

• You will be responsible for transferring and validating assay formulations, QC methods and testing processes into manufacturing; you will be responsible for creating and approving Product BOMs, Specs, Work Instructions and other documentation as the Design Transfer Lead for new assay introductions.

• You will drive, define and build-in business requirements and manufacturability requirements into the new product’s design transfer processes. 

• You will design and oversee appropriate stability studies for any new raw materials and/or formulations required for newly developed products, ensuring robust performance; you will lead QC development and implementation for new assays and underlying components.

• You have extensive biochemical knowledge and hands-on experience pertaining to chemical formulations, enzyme activity assays, and a thorough understanding of current molecular biology techniques.

• You have excellent Project Management successes with expertise influencing key decision makers within a matrix environment

• You will act as a catalyst and primary contact for multiple functional areas across project teams, present to senior management project status, plans, issues and recommendations as well as negotiate key stakeholders including Quality, Regulatory, Assay Development, and Operations.

This position is located on-site in Carlsbad, CA & Torrey Pines, CA.
There are no relocation benefits for this position.

Who You Are:
(Required)

• You have a PhD or Master’s degree in a biology, chemistry or scientific discipline, with 10+ years of experience in the healthcare/biotech/pharmaceutical industry

• You have experience in design transfer from product development to commercial manufacturing processes in the biotechnology arena, preferably in an FDA regulated environment   

• You have demonstrated, in-depth experience with process and product validations, specification setting and test method validations, and FDA design control documentation

• You have demonstrated leadership and project management experience within a matrix environment

Preferred:

• You have experience in molecular diagnostics product development

• You have experience leading design transfer activities for medical devices in international markets

• You have six sigma Green belt or Black Belt, and project management certifications 

• You have excellent organizational skills, including the ability to efficiently evaluate, prioritize and handle multiple changing projects and priorities

• You have strong written and verbal communication skills; including the ability to communicate with all levels within the organization.

• You have experience working collaboratively, fostering professional and constructive relationships as part of a team; while also working independently to produce data and meet challenging timelines and goals

WORK ENVIRONMENT

The essential functions of the job are usually performed in an environmentally controlled facility where the noise level in the work environment is usually moderate.  This position may involve a combination of office and biotechnology l